Clinical Trial Design Feasibility Assessment

Systematically assess clinical trial feasibility by analyzing 6 research dimensions. Produces comprehensive feasibility reports with quantitative enrollment projections, endpoint recommendations, and regulatory pathway analysis.

IMPORTANT: Always use English terms in tool calls (drug names, disease names, biomarker names), even if the user writes in another language. Only try original-language terms as a fallback if English returns no results. Respond in the user's language.

Core Principles

1. Report-First Approach (MANDATORY)

DO NOT show tool outputs to user. Instead:

Create [INDICATION]_trial_feasibility_report.md FIRST
Initialize with all section headers
Progressively update as data arrives
Present only the final report

2. Evidence Grading System

Grade	Symbol	Criteria	Examples
A	3-star	Regulatory acceptance, multiple precedents	FDA-approved endpoint in same indication
B	2-star	Clinical validation, single precedent	Phase 3 trial in related indication
C	1-star	Preclinical or exploratory	Phase 1 use, biomarker validation ongoing
D	0-star	Proposed, no validation	Novel endpoint, no precedent

3. Feasibility Score (0-100)

Weighted composite score:

Patient Availability (30%): Population size x biomarker prevalence x geography
Endpoint Precedent (25%): Historical use, regulatory acceptance
Regulatory Clarity (20%): Pathway defined, precedents exist
Comparator Feasibility (15%): Standard of care availability
Safety Monitoring (10%): Known risks, monitoring established

Interpretation: >=75 HIGH (proceed), 50-74 MODERATE (additional validation), <50 LOW (de-risking required)

When to Use This Skill

Apply when users:

Plan early-phase trials (Phase 1/2 emphasis)
Need enrollment feasibility assessment
Design biomarker-selected trials
Evaluate endpoint strategies
Assess regulatory pathways
Compare trial design options
Need safety monitoring plans

Trigger phrases: "clinical trial design", "trial feasibility", "enrollment projections", "endpoint selection", "trial planning", "Phase 1/2 design", "basket trial", "biomarker trial"

Core Strategy: 6 Research Paths

Execute 6 parallel research dimensions. See STUDY_DESIGN_PROCEDURES.md for detailed steps per path.

Trial Design Query
|
+-- PATH 1: Patient Population Sizing
|   Disease prevalence, biomarker prevalence, geographic distribution,
|   eligibility criteria impact, enrollment projections
|
+-- PATH 2: Biomarker Prevalence & Testing
|   Mutation frequency, testing availability, turnaround time,
|   cost/reimbursement, alternative biomarkers
|
+-- PATH 3: Comparator Selection
|   Standard of care, approved comparators, historical controls,
|   placebo appropriateness, combination therapy
|
+-- PATH 4: Endpoint Selection
|   Primary endpoint precedents, FDA acceptance history,
|   measurement feasibility, surrogate vs clinical endpoints
|
+-- PATH 5: Safety Endpoints & Monitoring
|   Mechanism-based toxicity, class effects, organ-specific monitoring,
|   DLT history, safety monitoring plan
|
+-- PATH 6: Regulatory Pathway
    Regulatory precedents (505(b)(1), 505(b)(2)), breakthrough therapy,
    orphan drug, fast track, FDA guidance

Report Structure (14 Sections)

Create [INDICATION]_trial_feasibility_report.md with all 14 sections. See REPORT_TEMPLATE.md for full templates with fillable fields.

Executive Summary - Feasibility score, key findings, go/no-go recommendation
Disease Background - Prevalence, incidence, SOC, unmet need
Patient Population Analysis - Base population, biomarker selection, eligibility funnel, enrollment projections
Biomarker Strategy - Primary biomarker, alternatives, testing logistics
Endpoint Selection & Justification - Primary/secondary/exploratory endpoints, statistical considerations
Comparator Analysis - SOC, trial design options (single-arm vs randomized vs non-inferiority), drug sourcing
Safety Endpoints & Monitoring Plan - DLT definition, mechanism-based toxicities, organ monitoring, SMC
Study Design Recommendations - Phase, design type, schema, eligibility, treatment plan, assessment schedule
Enrollment & Site Strategy - Site selection, enrollment projections, recruitment strategies
Regulatory Pathway - FDA pathway, precedents, pre-IND meeting, IND timeline
Budget & Resource Considerations - Cost drivers, timeline, FTE requirements
Risk Assessment - Feasibility risks, scientific risks, mitigation strategies
Success Criteria & Go/No-Go Decision - Phase 1/2 criteria, interim analysis, feasibility scorecard
Recommendations & Next Steps - Final recommendation, critical path to IND, alternative designs

Tool Reference by Research Path

PATH 1: Patient Population Sizing

OpenTargets_get_disease_id_description_by_name - Disease lookup
OpenTargets_get_diseases_phenotypes - Prevalence data
ClinVar_search_variants - Biomarker mutation frequency
gnomAD_search_gene_variants - Population allele frequencies
PubMed_search_articles - Epidemiology literature
search_clinical_trials - Enrollment feasibility from past trials

PATH 2: Biomarker Prevalence & Testing

ClinVar_get_variant_details - Variant pathogenicity
COSMIC_search_mutations - Cancer-specific mutation frequencies
gnomAD_get_variant_details - Population genetics
PubMed_search_articles - CDx test performance, guidelines

PATH 3: Comparator Selection

drugbank_get_drug_basic_info_by_drug_name_or_id - Drug info
drugbank_get_indications_by_drug_name_or_drugbank_id - Approved indications
drugbank_get_pharmacology_by_drug_name_or_drugbank_id - Mechanism
FDA_OrangeBook_search_drugs - Generic availability
FDA_get_drug_approval_history - Approval details
search_clinical_trials - Historical control data

PATH 4: Endpoint Selection

search_clinical_trials - Precedent trials, endpoints used
PubMed_search_articles - FDA acceptance history, endpoint validation
FDA_get_drug_approval_history - Approved endpoints by indication

PATH 5: Safety Endpoints & Monitoring

drugbank_get_pharmacology_by_drug_name_or_drugbank_id - Mechanism toxicity
FDA_get_warnings_and_cautions_by_drug_name - FDA black box warnings
FAERS_search_reports_by_drug_and_reaction - Real-world adverse events
FAERS_count_reactions_by_drug_event - AE frequency
FAERS_count_death_related_by_drug - Serious outcomes
PubMed_search_articles - DLT definitions, monitoring strategies

PATH 6: Regulatory Pathway

FDA_get_drug_approval_history - Precedent approvals
PubMed_search_articles - Breakthrough designations, FDA guidance
search_clinical_trials - Regulatory precedents (accelerated approval)

Quick Start Example

from tooluniverse import ToolUniverse

tu = ToolUniverse(use_cache=True)
tu.load_tools()

# Example: EGFR+ NSCLC trial feasibility
# Step 1: Disease prevalence
disease_info = tu.tools.OpenTargets_get_disease_id_description_by_name(
    diseaseName="non-small cell lung cancer"
)
prevalence = tu.tools.OpenTargets_get_diseases_phenotypes(
    efoId=disease_info['data']['id']
)

# Step 2: Biomarker prevalence
variants = tu.tools.ClinVar_search_variants(gene="EGFR", significance="pathogenic")

# Step 3: Precedent trials
trials = tu.tools.search_clinical_trials(
    condition="EGFR positive non-small cell lung cancer",
    status="completed", phase="2"
)

# Step 4: Standard of care comparator
soc = tu.tools.FDA_OrangeBook_search_drugs(ingredient="osimertinib")

# Compile into feasibility report...

See WORKFLOW_DETAILS.md for the complete 6-path Python workflow and use case examples.

Integration with Other Skills

tooluniverse-drug-research: Investigate mechanism, preclinical data
tooluniverse-disease-research: Deep dive on disease biology
tooluniverse-target-research: Validate drug target, essentiality
tooluniverse-pharmacovigilance: Post-market safety for comparator drugs
tooluniverse-precision-oncology: Biomarker biology, resistance mechanisms

Reference Files

File	Content
`REPORT_TEMPLATE.md`	Full 14-section report template with fillable fields
`STUDY_DESIGN_PROCEDURES.md`	Detailed steps for each of the 6 research paths
`WORKFLOW_DETAILS.md`	Complete Python example workflow and 5 use case summaries
`BEST_PRACTICES.md`	Best practices, common pitfalls, output format requirements
`EXAMPLES.md`	Additional examples
`QUICK_START.md`	Quick start guide

Version Information

Version: 1.0.0
Last Updated: February 2026
Compatible with: ToolUniverse 0.5+
Focus: Phase 1/2 early clinical development

tooluniverse-clinical-trial-design